Active Ingredients
MINOXIDIL 5%
Solucion Capilar Crecepelo Liquid
FDA Label NDC 78192-401
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boe Dominicana Srl for the product Solucion Capilar Crecepelo (NDC 78192-401). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, warnings, do not use if, ask a doctor before use if you have, when using this product, pregnancy section, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
| Active ingredients | Purpose |
| Minoxidil 5% W/V | Enhance hair appearance |
Use: Promote the appearence of fuller hair.
Warnings
For External Use Only
Flammable: Keep away from fire or flame
Do Not Use If
- You have no family history of hair loss .
- Your hair loss is sudden and/or patchy ·
- You do not know the reason for you hair loss. ·
- You are under 18 years of age.
- Do not use in babies or children. ·
- Your scalp is red, inflamed, infected, irritated, or painful.
Ask A Doctor Before Use If You Have
heart disease
When Using This Product
- Do not apply on other parts of the body.
- Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
- Some people have experienced changes in hair color and/or texture. ·
- It takes time to regrow hair. Results may occur at 2 months with twice a day usage.
- For some men, you may need to use this product for at least 4 months before you see results.
- The amount of hair is different for each person. This product will not work for all men.
Pregnancy Section
May be harmful if used when pregnant or breast-feeding.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Stop Use And Ask A Doctor If
- Chest pain, rapid heartbeat, faintness, or dizziness occurs. ·
- Sudden, unexplained weight gain occurs. ·
- Your hands or feet swell ·
- Scalp irritation or redness occurs ·
- Unwanted facial hair growth occurs.
- You do not see hair regrowth in 4 months.
Other Information
- Before use, read all information on carton.
- Keep the carton. It contains important information.
- Store at 20° to 25°C (68° to 77°F). Keep tightly closed.
Directions
- Apply one (1) mL with dropper 2 times a day directly onto the scalp in the hair loss area.
- Using more or more often will not improve results.
- Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
Indications & Usage
use as directed
Inactive Ingredient
Alcohol, propylene glycol, purified water.
Questions?
- Call (201) 608-5108
- Visit www.boeusa.com
Package Label.Principal Display Panel
NDC 78192-400-01
CRECEPELO®
MINOXIDIL
Enhances Hair Density Appearance
Mejora la apariencia de la densidad del cabello
TOPICAL SOLUTION USP 5%
Solución tópica USP, 5%
Helps hair look thicker and more voluminous.
Helps reduce the appearance of thinning hair
Boost hair volume and texture
Ayuda a que el cabello luzca más grueso y voluminoso. Ayuda a reducir la apariencia de cabello fino. Promueve el volumen y la textura del cabello
NOT FOR WOMEN
3 MONTH SUPPLY
Tratamiento de 3 mes
4 ampules 0.7 fl oz. each (92 mL)
Manufactured & Packed by: Boé Dominicana SRL, Ctra. de Ceuta km2, Santo Domingo Norte, RD
Distributed by: Boé Cosmetics USA Corporation, 73 Williams Street Belleville, NJ07109
* Please review the disclaimer below.
